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People With High Body Fat PercentageNCT06886048

Effects of Barley Green on Visceral Fat Area in the Human Body and Investigation Into the Associated Mechanism of Intestinal Microbiota

A study testing barley green in people with People With High Body Fat Percentage and People With High Visceral Fat Area, run by Peking University People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to investigate the changes in visceral fat area and associated indicators in individuals with high body fat percentage under the intervention of barley green, elucidate the clinical efficacy of barley green on human visceral fat, and preliminarily explore the mechanism by which barley green… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
barley green
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
19 Mar 2025to 25 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years old, gender is not limited; Body fat percentage exceeding the upper limit of the standard range: male > 20%, female > 28%; Visceral fat area > 100cm2; Willing to accept the assessment and sign informed consent.

Who cannot join

  • ① Patients currently receiving weight-loss medications (e.g., incretin-based therapies such as GLP-1 receptor agonists) or medications that improve insulin resistance (e.g., metformin or other insulin-sensitizing agents), or anti-inflammatory agents with documented effects on inflammatory markers (including but not limited to lipid-lowering agents, hypoglycemic agents, antihypertensives, urate-lowering agents, etc.);
  • Patients concurrently using nutritional supplements or functional foods (e.g., phytochemicals, health supplements) with demonstrated effects on reducing body fat or visceral adiposity;
  • Patients regularly consuming prebiotics, probiotics, or other microbiota-modulating agents;
  • Patients with diseases severely affecting nutrient digestion or absorption (e.g., chronic diarrhea, severe constipation, active inflammatory bowel disease, active gastrointestinal ulcers, history of gastrointestinal resection, cholecystitis/post-cholecystectomy syndrome, etc.);
  • Patients with cardiovascular/cerebrovascular diseases (e.g., coronary artery disease, heart failure, arrhythmias, cardiomyopathies, cerebral infarction, cerebral hemorrhage, cerebral arteritis), grade 3 hypertension, stroke, chronic hepatitis, malignancies, anemia, psychiatric disorders, cognitive impairment, epilepsy, acute-phase gout, nephrolithiasis, or renal insufficiency;
  • ⑥ Patients with hepatic dysfunction (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] levels exceeding 3 times the upper limit of normal [ULN]) or renal dysfunction (serum creatinine exceeding ULN);
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  • ⑦ Patients with active infectious diseases (e.g., tuberculosis, HIV/AIDS);
  • ⑧ Patients with severe allergies to any component of the investigational products;
  • ⑨ Pregnant or lactating individuals;
  • ⑩ Patients with physical disabilities or other conditions deemed ineligible by investigators (e.g., clinically significant comorbidities not listed above).

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University People's Hospital

    Beijing, Xicheng District, 100044

Other trials in China

About this study

The aim of this study was to investigate the changes in visceral fat area and associated indicators in individuals with high body fat percentage under the intervention of barley green, elucidate the clinical efficacy of barley green on human visceral fat, and preliminarily explore the mechanism by which barley green influences human visceral fat through gut microbiota analysis. Participants with high body fat percentage were recruited from the Clinical Nutrition Department of Peking University People's Hospital and randomly assigned to either an intervention group or a control group. The intervention group received a regimen combining barley green supplementation with a calorie-restricted balanced diet plan, while the control group followed only the calorie-restricted balanced diet plan. General clinical data were collected, nutritional assessments were conducted, and dynamic analyses of body composition and metabolism were performed. Venous blood samples were obtained for the measurement of metabolic and inflammation-related indices as well as gut microbiota characterization. By observing and comparing differences in visceral fat area and related parameters, as well as gut microbiota profiles between the two groups, this study provides a scientific foundation for the clinical application of barley green in medical nutrition interventions targeting populations with high body fat percentage.

Being tested
barley green

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • barley greenDietary supplement

    Oral administration: 30 minutes before meals Dosage: 4 g powder, 5 g tablet Frequency: 2 times a day

Study groups in NCT06886048
Study groupRoleWhat they receive
control groupNo interventionNot described
intervention groupExperimentalNot described
Receives: Dietary Supplement: barley green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. visceral fat area in cm2

    Visceral fat areas are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks.

Secondary outcomes (71)
  1. height in centimeters

    Height in centimeters are measured by Manual Height Ruler at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  2. weight in kilograms

    Weight in kilograms are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  3. BMI in kg/m^2

    Weight and height will be combined to report BMI in kg/m^2 at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  4. body fat rate in %

    Body fat rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  5. muscle mass in kilograms

    Muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  6. basal metabolic rate in kcal

    Basal metabolic rates are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  7. skeletal muscle mass in kilograms

    Skeletal muscle masses are measured by the Inbody 770 instrument at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  8. blood pressure in mmHg

    Blood pressures are measured by electronic blood pressure monitor at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  9. waist circumference in millimeters

    Waist circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  10. hip circumference in millimeters

    Hip circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  11. upper arm circumference in millimeters

    Upper arm circumferences are measured by tape measure at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  12. left hand grip strength in pound-force

    Left hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  13. right hand grip strength in pound-force

    Right hand grip strengths are measured by grip dynamometer at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  14. triceps skinfold thickness in millimeters

    Triceps skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  15. subscapular horn skinfold thickness in millimeters

    Subscapular horn skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  16. abdominal skinfold thickness in millimeters

    Abdominal skinfold thicknesses are measured by skin fold thickness gauge at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  17. food intake dose in grams

    Data of food intake doses are taken by food frequency questionnaire and 3-day food diary at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  18. uric acid levels in umol/L

    Uric acid levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  19. blood glucose in mmol/L

    Blood glucose levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  20. total cholesterol in mmol/L

    Total cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  21. triglycerides in mmol/L

    Triglycerides levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  22. high-density lipoprotein cholesterol in mmol/L

    High-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  23. low-density lipoprotein cholesterol in mmol/L

    Low-density lipoprotein cholesterol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  24. white blood cell count in 10^9/L

    White blood cell counts are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  25. hemoglobin in g/L

    Hemoglobin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  26. glutamic-pyruvic transaminase in U/L

    Glutamic-pyruvic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  27. glutamic oxalacetic transaminase in U/L

    Glutamic oxalacetic transaminase levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  28. albumin in g/L

    Albumin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  29. vitamin B6 in ng/mL

    Vitamin B6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  30. vitamin B1 in ng/mL

    Vitamin B1 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  31. vitamin B9 in ng/mL

    Vitamin B9 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  32. vitamin B5 in ng/mL

    Vitamin B5 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  33. vitamin B3 in ng/mL

    Vitamin B3 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  34. vitamin B2 in ng/mL

    Vitamin B2 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  35. vitamin B12 in ng/mL

    Vitamin B12 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  36. vitamin A in ng/mL

    Vitamin A levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  37. vitamin D in ng/mL

    Vitamin D levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  38. vitamin E in ng/mL

    Vitamin E levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  39. vitamin K in ng/mL

    Vitamin K levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  40. cobalt in µg/L

    Cobalt levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  41. nickel in µg/L

    Nickel levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  42. selenium in µg/L

    Selenium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  43. arsenic in µg/L

    Arsenic levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  44. platinum in µg/L

    Platinum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  45. copper in mg/L

    Copper levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  46. molybdenum in µg/L

    Molybdenum levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  47. zinc in mg/L

    Zinc levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  48. manganese in µg/L

    Manganese levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  49. magnesium in mg/L

    Magnesium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  50. cadmium in µg/L

    Cadmium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  51. iron in mg/L

    Iron levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  52. thallium in µg/L

    Thallium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  53. lead in µg/L

    Lead levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  54. calcium in mg/L

    Calcium levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  55. cortisol in µg/dL

    Cortisol levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  56. growth hormone in ng/mL

    Growth hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  57. fasting insulin in uU/mL

    Fasting insulin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  58. thyroid-stimulating hormone in uIU/mL

    Thyroid-stimulating hormone levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  59. free thyroxine in pmol/L

    Free thyroxine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  60. free triiodothyronine in pmol/L

    Free triiodothyronine levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  61. IL-1β in pg/mL

    IL-1β levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  62. IL-6 in pg/mL

    IL-6 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  63. IL-10 in pg/mL

    IL-10 levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  64. leptin in pg/mL

    Leptin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  65. adiponectin in µg/mL

    Adiponectin levels are measured by blood samples at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  66. Hardness of liver in kPa

    Hardness of liver is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  67. Controlled Attenuation Parameter in dB/m

    Controlled Attenuation Parameter is measured by Liver Ultrasound Elastography at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  68. Alpha diversity (Shannon index, Chao1)

    Alpha diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  69. Beta diversity (Bray-Curtis dissimilarity)

    Beta diversity is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  70. Relative abundance of specific taxa (e.g., Firmicutes/Bacteroidetes ratio)

    Relative abundance of specific taxa is measured by fecal specimen assessed by 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

  71. Predicted functional pathways (via metagenomic analysis)

    Predicted functional pathways are analyzed via metagenomic analysis after 16S rRNA sequencing at two time points: the day of enrollment and 8 weeks after enrollment.

    Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start19 Mar 2025
  3. Primary completion3 Jul 2026
  4. Study completion25 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886048
Sponsor's protocol ID
2024PHB574-001
Status last verified
Sep 2026
First submitted
14 Mar 2025
Last updated
16 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing barley green in people with People With High Body Fat Percentage and People With High Visceral Fat Area, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visceral fat area in cm2 (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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